NCT01991704

Brief Summary

In order to determine whether the 'incubation of craving' phenomenon also occurred in alcoholics, investigators employed an experimental approach to investigate the time course of cue-induced craving in alcoholism. Eighty male participants were randomly divided into Four groups, and they were assessed at 7, 14, 30, and 60 days of abstinence for cue-induced alcohol craving . Another group including 19 patients was repeatedly tested for the cue-induced alcohol craving at the above abstinence days. Other psychological and physiological measures were administered at the four abstinence time points.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1.4 years

First QC Date

November 8, 2013

Last Update Submit

November 18, 2013

Conditions

Alcohol Dependence

Keywords

incubationCravingalcohol dependence

Outcome Measures

Primary Outcomes (1)

  • changes of alcohol craving measured with visual analogue scales

    abstained from alcohol for 7 days, 14 days, 30 days and 60 days

Secondary Outcomes (4)

  • heart rate changes

    7, 14, 30 and 60 days after abstained

  • blood pressure changes in different abstinence days

    7, 14, 30 and 60 days after abstained

  • skin conductance changes in different abstinence days

    7, 14, 30 and 60 days after abstained

  • changes of Alcohol Urge Questionnaire

    7, 14, 30 and 60 days after abstained

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

alcohol dependence

You may qualify if:

  • met the criteria of DSM-IV for alcohol dependence
  • aged 18-60 years,male

You may not qualify if:

  • current or past history of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) axis I disorders
  • with other serious physical diseases (respiratory disorders, cardiovascular disease and so on)
  • other drug abuse except for nicotine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: NONE RETAINED

The blood samples of all participants were collected at each point of withdrawal.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Lin Lu, Prof.

    National Institute on Drug Dependence, China

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2013

First Posted

November 25, 2013

Study Start

October 1, 2011

Primary Completion

March 1, 2013

Study Completion

October 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11